Quality of Life and Glucose Control After 1 Year of Nationwide Reimbursement of Intermittently Scanned Continuous Glucose Monitoring in Adults Living With Type 1 Diabetes (FUTURE): A Prospective Observational Real-World Cohort Study.

Abstract

In 2016, nationwide reimbursement of intermittently scanned continuous glucose monitoring (isCGM) for people living with type 1 diabetes treated in specialist diabetes centers was introduced in Belgium. We undertook a 12-month prospective observational multicenter real-world study to investigate impact of isCGM on quality of life and glycemic control. Between July 2016 and July 2018, 1,913 adults with type 1 diabetes were consecutively recruited in three specialist diabetes centers. Demographic, metabolic, and quality of life data were collected at baseline, 6 months, and 12 months of standardized clinical follow-up. The primary end point was evolution of quality of life from baseline to 12 months. Secondary outcome measures were, among others, change in HbA_1c, time spent in different glycemic ranges, occurrence of acute diabetes complications, and work absenteeism. General and diabetes-specific quality of life was high at baseline and remained stable, whereas treatment satisfaction improved (<i>P</i> < 0.0001). Admissions for severe hypoglycemia and/or ketoacidosis were rare in the year before study (<i>n</i> = 63 out of 1,913; 3.3%), but decreased further to 2.2% (<i>n</i> = 37 out of 1,711; <i>P</i> = 0.031). During the study, fewer people reported severe hypoglycemic events (<i>n</i> = 280 out of 1,913 [14.6%] vs. <i>n</i> = 134 out of 1,711 [7.8%]; <i>P</i> < 0.0001) or hypoglycemic comas (<i>n</i> = 52 out of 1,913 [2.7%] vs. <i>n</i> = 18 out of 1,711 [1.1%]; <i>P</i> = 0.001) while maintaining HbA_1c levels. Fewer people were absent from work (<i>n</i> = 111 out of 1,913 [5.8%] vs. <i>n</i> = 49 out of 1,711 [2.9%]; <i>P</i> < 0.0001). Time spent in hypoglycemia significantly decreased in parallel with less time in range and more time in hyperglycemia. Eleven percent (<i>n</i> = 210) of participants experienced skin reactions, leading to stopping of isCGM in 22 participants (1%). Nationwide unrestricted reimbursement of isCGM in people with type 1 diabetes treated in specialist diabetes centers results in higher treatment satisfaction, less severe hypoglycemia, and less work absenteeism, while maintaining quality of life and HbA_1c.